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MAMMOMAT Inspiration (Siemens) – Incorrect Table Installation (2025)

There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.

Moderate

FDAOct 24, 2025Nationwide• Siemens Medical Solutions USA, Inc

Cardiosave Rescue (Datascope) – IFU Vibration Standards Update (2025)

The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

High

FDAOct 23, 2025Nationwide• Datascope Corp.

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MAMMOMAT Inspiration (Siemens) – Incorrect Table Installation (2025)

Cardiosave Rescue (Datascope) – IFU Vibration Standards Update (2025)

Cardiosave Hybrid (Datascope) – IFU Vibration Standards Update (2025)

BD Kiestra Cuvette Array (Becton Dickinson) – Barcode Formatting Error (2025)

BioFire Respiratory Panel 2.1 (BioFire) – False Negative Risk (2025)

CareLink Clinic (Medtronic) – Graph Data Inaccuracy (2025)

VerifyNow PRUTest (Accriva) – Unauthorized Device Distribution (2025)

HR-ACT Cartridges (Medtronic) – External Label Contamination (2025)

Isoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

Sevoflurane V90 Vaporizer (Mindray) – Anesthesia Leakage Risk (2025)

MONARCH Bronchoscope (Auris Health) – Leak Test Deviation (2025)

IntelePACS (Intelerad) – Software Communication Bug (2025)

Multichem ID-B (Techno-Path) – HBsAg Recovery Issue (2025)

MAHURKAR Catheter Tray (Mozarc) – Packaging Seal Integrity (2025)

Emdogain (Straumann) – Unintended Patient Use Risk (2025)

EZDilate Nephrostomy Catheter (Olympus) – Incorrect Balloon Size (2025)

BD Alaris Infusion Pump Module (CareFusion) – Infusion Regulation Risk (2025)

VANTAGE GALAN 3T (Canon Medical) – Electrode Distance Compliance (2025)

Ceiling Type X-Ray Tube Support (Shimadzu) – Mounting Shaft Risk (2025)

BD Luer Tip Caps (Becton Dickinson) – Biocompatibility Failure (2025)